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Multimodal Treatments for Chronic Lower Back Pain (BACPAC Trial)
Phase 4
Recruiting
Led By Afton Hassett, PsyD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Acupressure: Currently receiving acupressure or acupuncture through formal therapy
Normal visual acuity or correctable (with corrective lenses- glasses or contacts) to at least 20/40 for reading instructions in the MRI and visual sensitivity testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6 (t2), week 15 (t3)
Awards & highlights
BACPAC Trial Summary
This trial will help identify who benefits from different chronic pain treatments and how these treatments work.
Who is the study for?
This trial is for individuals with chronic lower back pain lasting at least six months, who are right-handed, can lie still for MRI scans, and don't have severe health issues like osteoporosis or uncontrolled addiction. Participants must not be pregnant, involved in other conflicting studies, expecting surgery within a year, or on high opioid doses.Check my eligibility
What is being tested?
The study tests four treatments: mindfulness-based stress reduction (MBSR), physical therapy with exercise, self-administered acupressure, and the medication duloxetine. After an initial assessment period using PainGuide and MRIs among others tools participants may receive two different treatments sequentially if they still have significant pain.See study design
What are the potential side effects?
Possible side effects include typical reactions to mindfulness practices such as discomfort during meditation; physical therapy might cause muscle soreness; acupressure could result in bruising or tenderness; duloxetine may lead to nausea, dry mouth, sleepiness or dizziness.
BACPAC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently undergoing acupressure or acupuncture therapy.
Select...
My vision, with glasses or contacts, is good enough to read MRI instructions.
Select...
I can stay still on my back for 2 hours.
BACPAC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 6 (t2), week 15 (t3)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6 (t2), week 15 (t3)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a between week 6 to week 15
Secondary outcome measures
Change in Patient Global Impression of Change (PGIC) from week 6 to week 15
Dental Pins
BACPAC Trial Design
17Treatment groups
Experimental Treatment
Group I: PainGuideExperimental Treatment1 Intervention
Run-in treatment only with no additional treatments.
Group II: PT and exercise then MBSRExperimental Treatment4 Interventions
Run-in treatment, then 8 weeks of PT and exercise, and then 8 weeks of MBSR.
Group III: PT and exercise then DuloxetineExperimental Treatment4 Interventions
Run-in treatment, then 8 weeks of PT and exercise, and then approximately 8 weeks of Duloxetine
Group IV: PT and exercise then AcupressureExperimental Treatment4 Interventions
Run-in treatment, then 8 weeks of PT and exercise, and then 8 weeks of Acupressure
Group V: PT and exerciseExperimental Treatment3 Interventions
Run-in treatment then PT and exercise
Group VI: MBSR then PT and exerciseExperimental Treatment4 Interventions
Run-in treatment then 8 weeks of MBSR, and then 8 weeks of PT and exercise.
Group VII: MBSR then DuloxetineExperimental Treatment4 Interventions
Run-in treatment, then 8 weeks of MBSR, and then approximately 8 weeks of Duloxetine
Group VIII: MBSR then AcupressureExperimental Treatment4 Interventions
Run-in treatment, then 8 weeks of MBSR, and then 8 weeks Acupressure.
Group IX: MBSR (mindfulness-based stress reduction)Experimental Treatment3 Interventions
Run-in treatment then MBSR.
Group X: Duloxetine then PT and exerciseExperimental Treatment4 Interventions
Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks of PT and exercise
Group XI: Duloxetine then MBSRExperimental Treatment4 Interventions
Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks of MBSR.
Group XII: Duloxetine then AcupressureExperimental Treatment4 Interventions
Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks Acupressure.
Group XIII: DuloxetineExperimental Treatment3 Interventions
Run-in treatment then Duloxetine
Group XIV: Acupressure then PT and exerciseExperimental Treatment4 Interventions
Run-in treatment, then 8 weeks of Acupressure, and then 8 weeks of PT and exercise.
Group XV: Acupressure then MBSRExperimental Treatment4 Interventions
Run-in treatment, then 8 weeks of Acupressure, and then 8 weeks of MBSR
Group XVI: Acupressure then DuloxetineExperimental Treatment4 Interventions
Run-in treatment, then 8 weeks of Acupressure, and then approximately 8 weeks of Duloxetine
Group XVII: AcupressureExperimental Treatment3 Interventions
Run-in treatment then Acupressure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MBSR
2016
Completed Phase 3
~1940
Duloxetine
2011
Completed Phase 4
~4170
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,377,638 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
484 Previous Clinical Trials
1,086,345 Total Patients Enrolled
Afton Hassett, PsyDPrincipal Investigator - University of Michigan
University of Michigan
1 Previous Clinical Trials
2 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any medications that are excluded by the study.You have a history that makes it unsafe for you to have an MRI scan.You have had an allergic reaction to duloxetine in the past.I am scheduled for an injection or surgery for my chronic lower back pain within a year.You have received disability payments or been involved in a lawsuit in the past year.I can avoid alcohol and nicotine on the day of my test.I am being treated for osteoporosis with more than just vitamins.You have had ongoing low back pain for at least six months, and it is present on more than half of those days.You've been using fake nails or nail enhancements a lot in the past 6 months.I have had a spinal fracture in the past 6 months.I am currently undergoing acupressure or acupuncture therapy.I have been diagnosed with nerve damage in my hands or feet.My liver tests are up to 1.5 times the normal limit.I am scheduled for, or had back surgery within the last year, or had multiple back surgeries.I cannot receive acupressure due to health reasons.My kidney function is very low or I have end-stage renal failure.I have a history of cancer involving bones or have been treated for any cancer in the last 2 years.You are very afraid of being in tight spaces and cannot have certain tests done because of it.I am open to being assigned any of the four treatment options.I have a history of specific autoimmune diseases like rheumatoid arthritis or lupus.I take more than 100mg of morphine or its equivalent daily.I am currently undergoing physical therapy or exercise for low-back pain.I am currently undergoing acupressure or acupuncture therapy.I do not have severe vision or hearing problems.You have other medical or mental health conditions that the study doctors believe would make it too risky for you to participate. This could include severe mental health issues, thoughts of suicide, history of attempting suicide, or uncontrolled drug or alcohol addiction.You primarily use your right hand for activities like writing or throwing and catching a ball.I cannot do physical therapy or exercise due to health reasons.I can avoid taking any pain relief medications like Advil or Tylenol for 8 hours before certain tests.I have had cauda equina syndrome or spinal nerve root problems causing weakness.You have a problem with drugs or alcohol that you can't control.You are expected to live for less than 2 years.I have had a spine infection or tumor in the past.I have no health issues preventing me from participating in mindfulness-based stress reduction (MBSR).I cannot participate in physical therapy or exercise due to health reasons.You have a very high body mass index (BMI) or cannot comfortably fit inside the MRI machine.You need to have a certain level of pain interference according to the PROMIS Pain Interference assessment.I cannot take duloxetine due to health reasons.I am currently undergoing physical therapy or exercise for low-back pain.My vision, with glasses or contacts, is good enough to read MRI instructions.I cannot speak or write in English.I can stay still on my back for 2 hours.You are currently taking part in a structured MBSR program.Your low back pain has been around for at least six months and bothers you on most days.
Research Study Groups:
This trial has the following groups:- Group 1: MBSR then Duloxetine
- Group 2: PainGuide
- Group 3: PT and exercise then Acupressure
- Group 4: MBSR then Acupressure
- Group 5: PT and exercise then MBSR
- Group 6: Duloxetine then PT and exercise
- Group 7: Duloxetine then Acupressure
- Group 8: MBSR (mindfulness-based stress reduction)
- Group 9: PT and exercise
- Group 10: Acupressure
- Group 11: Duloxetine
- Group 12: MBSR then PT and exercise
- Group 13: PT and exercise then Duloxetine
- Group 14: Acupressure then MBSR
- Group 15: Acupressure then PT and exercise
- Group 16: Acupressure then Duloxetine
- Group 17: Duloxetine then MBSR
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the criteria for this clinical experiment extend to participants in their mid-forties or beyond?
"This study is open to individuals aged 25-70. There are 12 trials available for minors and 277 studies that focus on patients over 65 years old."
Answered by AI
Is this research team currently looking for participants?
"Affirmative. Clinicaltrials.gov confirms that this trial is currently recruiting patients, with the first post being on June 9th 2021 and last edited on June 13th 2022. 500 individuals need to be admitted from one site in order for the study to continue progressing."
Answered by AI
What remedial treatment do physical therapy and exercise typically provide?
"Physiotherapy and exercise can provide therapeutic benefits for those with diabetic peripheral neuropathy (DPN). Additionally, it can be employed to address knee problems, major depressive disorder (MDD), as well as issues pertaining to the musculoskeletal system."
Answered by AI
Are there certain qualifications that must be met to partake in this medical experiment?
"Eligibility for this trial necessitates sufferers of chronic lower back pain (CLBP) between the ages 25 and 70. Five hundred participants are needed in order to meet recruitment goals."
Answered by AI
Could you please elucidate on any other research projects that have studied the relationship between physical therapy and exercise?
"Currently, there are 22 medical experiments assessing the efficacy of physical therapy and exercise. Of these studies, 4 have reached Phase 3. Although Redwood City, California houses many of the investigations for PT and exercise, globally 781 sites operate trials related to this field."
Answered by AI
How many individuals are being accepted into this clinical trial program?
"Affirmative. Clinicaltrials.gov evidences that this clinical experiment, which was initially posted on June 9th 2021, is actively seeking participants. The study requires the recruitment of 500 individuals from a single medical centre."
Answered by AI
Are physical therapy and exercise activities associated with any severe risks?
"Power's assessment of the safety profile for physical therapy and exercise is a 3, as it has been approved in Phase 4 clinical trials."
Answered by AI
Who else is applying?
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria
What questions have other patients asked about this trial?
1. How much should I expect this trial to pay?
2. What length of time should I expect this trial to take in order to complete and receive compensation?
3. Will this trial require time outside of in-office visits at the Ann-Arbor trial location? If so, how much time and in what ways?
4. How long should I expect the screening process to take?
PatientReceived 1 prior treatment
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